Henry Hidalgo

About Henry Hidalgo

Senior Quality Manager with 19 years of experience in quality systems for medical devices.Specialties: ISO 13485:2016 & cGMP regulatory requirements, FDA 21 CFR Part 820 regulations, CFR Part 11 Compliance, BSI/TUV Notified Body Audits, Project place, Sharepoint, Arena PLM, Agile PLM, Minitab, Quantum, Hazard/Risk Analysis, GD & T, Product Development, Design Control, Electronic Documentation PLM System Implementation, Internal Quality Auditing, Supplier Quality Auditing, Supplier Quality Assurance, Customer Complaint Handling, Customer Audits, NCMRs, Temporary Deviations, Device History Record Review, Final Product Lot Release, Incoming Inspection, CAPAs, Calibration System, Preventative Maintenance, Statistical Analysis Techniques (SPC and DOE), Precision Injection Molding, High-End Metrology, Failure Analysis, HHE, X-Ray Failure Analysis, Engineering Project Management, Six Sigma, Lean Manufacturing, Gap Analysis, Master Validation Plan Management, Technology Transfer Management, Robotics, and Semi-Automated/Fully Automated Assembly. Also, Microbiology/Chemistry Test Methods, Clean Room Validation, Environmental Controls, Product Aging Stability/Shelf Life, EO Parametric Release, Dry-Heat/Steam/Ethylene Oxide/Gamma, Vapor Hydrogen Peroxide Sterilization Methods, RO-DI Purified water systems, Sterilization Enhancement Validation, and Microbiology Test Lab Set Up.

Experience

1. Senior Quality Assurance Consultant

   Medicept Inc

   Jun 2018 — Present

   Expertise in CAPA System Management, Complaint Handling, Microbiology, Clean Room Class 7/8 Validation, EtO/Gamma Sterilization Validation, Sterilization Process Optimization, electronic QMS validation, 21 CFR part 11 compliance, ISO 13485:2016, ISO 14971:2012, Supplier Quality Assurance Management, Regulatory Audits, Supplier Audits, Internal Audit Management, Project Management, Process Validation, IQ/OQ/PQ, Non-Product Software Validation, Statistical Analysis, etc.

Education

• University of Massachusetts Lowell

  Mechanical Engineering of Technology, Mechanical Engineering

  2003 — 2014

• Salem State University

  Bachelors, BioChemistry

  1995 — 1999

Skills

• Quality System
• Iso 13485
• Validation
• Six Sigma
• Design of Experiments
• Quality Assurance
• Medical Devices
• Lean Manufacturing
• Automation
• Quality Control
• Capa
• Product Development
• Design Control
• Technology Transfer
• Injection Molding
• Iso
• Fda
• V&V
• R&D
• Microbiology
• Dmaic
• Spc
• Root Cause Analysis
• Quality Management
• Quality Auditing
• Gmp
• Fmea